Atherosclerotic cardiovascular disease (ASCVD) is the most prevalent health problem in the developed world. The incidence of ASCVD has grown at an alarming rate due to shifts in people's lifestyles. These shifts are primarily changes in diet, but also include decreases in physical activity and increases in stress levels. They have been accompanied by a rising onset of adult diabetes and body weight gain. This condition is now being referred to as metabolic syndrome.
According to the Executive Summary of the 18 Oct. 2005 article, “Diagnosis and Management of the Metabolic Syndrome, An American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement”:                “This Executive Summary is a synopsis of the full scientific statement from the American Heart Association (AHA) and the National Heart, Lung, and Blood Institute (NHLBI), which is intended to provide up to date guidance for professionals on the diagnosis and management of the metabolic syndrome in adults.        The metabolic syndrome has received increased attention in the past few years. It consists of multiple, interrelated risk factors of metabolic origin that appear to directly promote the development of atherosclerotic cardiovascular disease (ASCVD). This constellation of metabolic risk factors is strongly associated with type 2 diabetes mellitus or the risk for this condition. The metabolic risk factors consist of atherogenic dyslipidemia (elevated triglycerides and apolipoprotein B, small LDL particles, and low HDL cholesterol [HDL-C] concentrations), elevated blood pressure, elevated plasma glucose, a prothrombotic state, and a proinflammatory state.”        (For more details, see complete report of the same title of the same date.)        
The most significant indicator of ASCVD and coronary risk is hypercholesterolemia or a high cholesterol level. Originally, tests simply tested total cholesterol, but now more sophisticated tests called lipid or cholesterol panels measure the separate components of cholesterol: low density lipoproteins or “LDLs” (known as the undesirable, or “bad” cholesterol), high density lipoproteins or “HDLs” (the desirable, or “good” cholesterol), very low density lipoproteins or “VLDLs”, and triglycerides. Both the LDL to HDL ratio and LDLs alone are used to compute coronary heart disease risk factors.
The causal relationship is well established with the higher the LDL level or LDL:HDL ratio, the greater the risk of coronary heart disease. The Adult Treatment Panel III (ATP III) of the National Cholesterol Education Program issued an evidence-based set of guidelines in 2001, and then in 2004 published an update in Circulation labeled “Implications of Recent Clinical Trials for the National Cholesterol Education Program. Adult Treatment Panel III Guidelines.” The improvements and knowledge gained in the five major clinical trials discussed in the latter paper provide valuable background into the understanding of the utility of the present invention.
The most-prescribed drugs in America are statins (HMG-CoA reductase inhibiters), which are drugs to help reduce high LDL-levels. The present invention is as effective as statins in reducing the LDL (“bad cholesterol”) levels, and, unlike statins, it also increases the HDL (“good cholesterol”) levels and reduces the triglyceride levels. In Table 1 of the AHA/NHLBI document cited above, low HDLs and high triglycerides are now earmarked as two of the diagnostic criteria for the indication of metabolic syndrome. Concerning LDL reduction, both statins and the present invention reduce the LDL number in a standard lipid panel (the standard lipid panel does not differentiate between large and small particle LDLs). However, there is a significant difference in the nature and mechanism of the LDL reduction of statins and the present invention. Statins primarily reduce the large particle LDLs, while the present invention primarily reduces the more problematic small particle LDLs (see “Executive Summary” referenced above).
The present invention also appears to be useful in alleviating symptoms of other related diseases. More specifically, the ability of the invention to markedly reduce or eliminate symptoms of osteoarthritis and seasonal allergies in participants who have had these problems has been demonstrated. The fact that the regime of the invention reduces arterial stiffness may have beneficial effects on other health concerns as well. Specifically, it appears that Alzheimer's disease and dementia can be caused at least in part by “micro-strokes”. Arterial stiffness can lead to stroke. The invention may also be useful in reducing these conditions.
This invention achieves these significant changes without the use of pharmacological agents, but rather through the use of a specific nutritional regimen (described more specifically below) which shifts the subject's mode of metabolism.